De Mayo Hip Positioner® - Loaner De Mayo Hip Positioner® Case - Second - Innovative Medical Products, Inc

Duns Number:147363154

Device Description: Loaner De Mayo Hip Positioner® Case - Second Version

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More Product Details

Catalog Number

1101- CASE II LOANER

Brand Name

De Mayo Hip Positioner®

Version/Model Number

1101- CASE II LOANER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

9893424a-e660-4089-9890-ccfec1c2375c

Public Version Date

November 15, 2019

Public Version Number

1

DI Record Publish Date

November 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATIVE MEDICAL PRODUCTS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 518